Head of CMC Program Management

About Aura: At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery.  By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Position Summary:

Reporting to the Head of Technical Operations, the Head of CMC Program Management, is responsible for all program management activities within the CMC organization, including the development and monitoring of program strategy plans, timelines and budgets, and acting as the SME.  The incumbent will utilize program management standard methodologies while partnering with CMC functional leads to further develop and manage the integrated CMC project plan.  The Director, Technical Program Lead will provide project management expertise to ensure CMC activities are executed in coordination with and support of the integrated product development plan for clinical-stage and predevelopment-stage programs at Aura Biosciences.

Responsibilities include but are not limited to:

  • Develop and execute the CMC strategy by working in collaboration with cross-functional teams and leading operational planning and implementation of CMC program plans
  • Integrate clinical, regulatory, and commercial timelines into CMC strategy
  • Facilitate internal CMC decision-making processes and preparing regular updates for senior management and other key stakeholders
  • Manage external vendors and tech transfers to enable efficient and effective manufacturing, testing, stability, storage and logistics, CMC regulatory documentation preparation & review, and other related CMC operations
  • Oversight of CMOs, including alliance management, supply chain activities, budgets and proposals; coordinate internal program timelines and priorities with external CMOs
  • Maintain program-related CMC specific documentation, including, but not limited to, program plans, timelines, budget, and inventory
  • Drive complex initiatives from conception through successful completion by overseeing the development of an actionable roadmap including internal and external deliverables
  • Manage requests for information and prepare progress reports and ad hoc reports as required; coordinate compilation of data and implement best practices assuring project timelines are met
  • Proactively identify knowledge gaps and risks, and work with teams to develop mitigation plans

Minimum Requirements:

  • Bachelors or Master’s degree
  • 5+ years of industry experience within project/program management
  • Deep understanding of pharmaceutical drug development; in-depth knowledge of CMC functions, including analytical development & stability programs, clinical trial materials, manufacturing, quality & regulatory requirements
  • Ability to critically analyze data, compile technical reports, and business presentations
  • Strong oral and written communication skills. Ability to influence cross-functionally in a matrix environment.
  • Experience in planning systems and tools (MS Project, Excel, Gantt, etc.)
  • Ability to accomplish projects by deadline in a dynamic environment

Interested?  Email a cover letter and a copy of your CV to referencing the position description in the subject line.